Nutritional composition

ABSTRACT

The present invention provides nutritional compositions that are employed as oral supplementation to the human diet. The compositions of the present invention provide for supplementation to the diet of the cancer patient, as well as preventative dietary supplementation aimed at supporting the human immune system for those not currently suffering from cancer. The present invention is comprised of specific combinations of selected forms of unique sets of certain vitamins, minerals, protein, carbohydrates and phytochemicals.

This application is a continuation of U.S. patent application Ser. No.15/205,786, filed on Jul. 8, 2016, which is a divisional application ofU.S. patent application Ser. No. 13/852,472, filed Mar. 28, 2013. Theseand all other referenced extrinsic materials are incorporated herein byreference in their entirety. Where a definition or use of a term in areference that is incorporated by reference is inconsistent or contraryto the definition of that term provided herein, the definition of thatterm provided herein is deemed to be controlling.

FIELD OF THE INVENTION

The present invention relates to nutritional compositions useful forincreasing the efficacy of cancer therapies, including chemotherapy,radiation and target therapies; and more specifically to nutritionalcompositions to promote anti-tumor activity.

BACKGROUND

The following description includes information that may be useful inunderstanding the present invention. It is not an admission that any ofthe information provided herein is prior art or relevant to thepresently claimed invention, or that any publication specifically orimplicitly referenced is prior art.

Cancer is one of the most deadly diseases of all mankind. Preventing andtreatment of cancer is, therefore, and extremely important endeavor formankind to pursue. Much progress has been made over the last 50 yearsfor the treatment of cancer, including chemotherapeutic, radiation andmost recently, target therapies. A major shortcoming of thesetherapeutic treatments is their harmful effects to the human systemsince, in many cases, the practice of such therapies causes severeweight loss, hair loss, and in many cases, death.

It is believed that one of the major causes of the ill-effects of cancertherapies is that they tax the human immune system. A healthy and potenthuman immune system is very important to combat the ill-effects of thecancer therapies. The present invention overcomes the shortcomings ofthe art of cancer therapy by providing compositions that work togetherto enhance the immune system such that the health of the cancer patientis not compromised by the harsh effects of the cancer therapies, and asa result, can overcome such effects, resulting in more efficient cancerremedial therapeutic treatments.

SUMMARY OF THE INVENTION

The present invention provides nutritional compositions that areemployed as oral supplementation to the human diet. The compositions ofthe present invention provide for supplementation to the diet of thecancer patient, as well as preventative dietary supplementation aimed atsupporting the human immune system for those not currently sufferingfrom cancer.

It is a prime objective of the present invention to provide nutritivecompositions that when used in combination with radiation, target orchemotherapy, provide for an increased activity in combating neoplasticgrowth.

It is another objective of the present invention to provide foranti-neoplastic effects by dietary supplementation utilizing specificforms of nutrients such as selenium yeast and fish oil.

It is another objective of the present invention to provide forcompositions that help prevent cancer.

DETAILED DESCRIPTION

The present invention teaches a combination of specific nutrientssuitable for oral consumption by the human body. The compositions of thepresent invention when orally ingested on a daily basis, in combinationwith or without therapeutic treatments for cancer, specificallychemotherapy, target therapy and radiation therapy, work in asynergistic fashion together to aid the cancer patient in eliminatingthe cancer, healing of the cancer and recovery from the cancer. Thecompositions of the present invention may also be ingested on a daily,or periodic basis to help prevent cancer.

Although the mechanism of action of the compositions of the presentinvention are not well understood, many cases have been reported ofcancer patients benefiting from the use of the present invention incombination with the therapeutic treatments for cancer. It is believedthat the key ingredients of the present invention work synergisticallytogether to aid in the anti-neoplastic processes. The recent publicationentitled “Reduction of Splenic Immunosuppressive Cells and Enhancementof Anti-Tumor Immunity by Synergy of Fish Oil and Selenium Yeast” (Wangh, Chan Y-L, et al. (2013) PLoS ONE 8(1):e52912. Dol: I0.1371/journal.pone.005912) provides evidence that indeed thecompositions of the present invention provide said synergistic action,and also that the compositions taught by the present invention are noveland useful for the prevention and treatment of cancer.

These compositions include as preferred embodiment selenium. Thepreferred form of selenium is selenium yeast. The preferred amount ofselenium yeast is from about 5 mcg to about 500 mcg, and more preferredbetween about 10 mcg to about 250 mcg, and most preferably from between25 mcg to about 150 mcg. The preferred selenium yeast are Saccharomycescerevisiae, Saccharomyces exiguous, Saccharomyces pastorianus,Saccharomyces boulardii, Saccharomyces bayanus, Saccharomyces eubayanus,Saccharomyces florentinus, Saccharomyces fragilis.

Another essential ingredient of the present invention is fish oil. Thepreferred fish oil has an EDA/DHA ratio of from between 1 part EPA toabout 5 parts DHA, and from between 5 parts EPA to 1 part DHA, and morepreferably from about 2 parts EPA to 1 part DHA, and most preferablyfrom about 3 parts EPA to about 2 parts DHA. The EPAIDHA content of thefish oil preparations of the present invention are from between 10% toabout 90%, more preferably from between 30% to about 70% and mostpreferably from about 40% to about 60%. The preferred amounts of fishoil EPAIDHA preparation of the present invention is from 0.50 mg toabout 1.5 g, and more preferably between 250 mg to about 1000 mg, andmost preferably between 350 mg to about 750 mg.

Another essential component of the present invention is Beta Carotene.The preferred form of beta carotene is the naturally occurring form. Thepreferred amount is between 500 iu and 10,000 iu, and more preferablybetween 1500 iu and 7500 iu, and most preferably between about 1000 iuand 3000 iu.

Resverotrol is another important nutrient of the present invention. Thepreferred form of Resverotrol is from plan extract. The preferred amountof Resverotrol in the extract is from between 50% to about 98%, and mostpreferably about 95%. The preferred amount of Resverotrol extract to beemployed in the present invention is from about 5 mg to about 1500 mg,and more preferably from about 50 mg to about 300 mg, and mostpreferably from about 75 mg to about 150 mg.

Additionally, Vitamin D3 may be added to the nutritional compositions ofthe present invention. The preferred form of Vitamin D3 isCholecalciferol. The preferred amount of Vitamin D3 is from between 50iu and 3000 iu, and more preferably between from about 70 iu to about500 iu, and most preferably from about 100 iu to about 250 iu.

Another prime nutrient that may be included in the embodiments of thepresent invention is Vitamin K. The preferred form of Vitamin K isPhytonadione. The preferred amount of Vitamin K is between 2.5 mcg toabout 250 mcg, more preferably from between 15 mcg to about 100 mcg, andmost preferably between 20 mcg to about 75 mcg.

Another nutrient important to the efficacy of the present invention isVitamin B6. The preferred form of Vitamin B6 is Pyridoxinehydrochloride. The preferred amount is between 0.1 mg to about 100 mg,most preferably between about 0.5 mg to about 25 mg, and most preferablyfrom about 0.75 mg to about 10 mg.

Additionally, Vitamin B12 may be included in the present invention. Thepreferred form of Vitamin B12 is Cyanocobalamin. The preferred amount ofVitamin B12 is between about 0.3 mcg to about 900 mcg, most preferablybetween about 0.75 mcg to about 50 mcg, and most preferably between 1mcg and 10 mcg.

Another nutrient that is important to the present invention is FolicAcid. The preferred amount of Folic Acid is between about 25 mcg toabout 1000 mcg, most preferably between about 100 mcg to about 750 mcg,and most preferably between 200 mcg and 400 mcg.

The mineral Zinc is important to include in the present invention. Thepreferred amount of Zinc is between about 0.65 mcg to about 4000 mcg,most preferably between about 1 mcg to about 400 mcg, and mostpreferably between 3 mcg and 50 mcg.

The mineral Chromium is important to include in the present invention.The preferred form of Chromium is from yeast. The preferred amount ofChromium is between about 30 mcg to about 3000 mcg, most preferablybetween about 50 mcg to about 500 mcg, and most preferably between 25mcg and 100 mcg.

The mineral Molybdenum is important to include in the present invention.The preferred form of Molybdenum is from yeast. The preferred amount ofMolybdenum is between about 2.5 mcg to about 1000 mcg, most preferablybetween about 10 mcg to about 130 mcg, and most preferably between 15mcg and 60 mcg.

The amino acid glutamine is important to include in the presentinvention. The preferred amount of glutamine is between about 2.1 g toabout 250 g, most preferably between about 11 g to about 135 g, and mostpreferably between 10 g and 50 g.

The amino acid arginine is important to include in the presentinvention. The preferred amount of arginine is between about 0.71 g toabout 25 g, most preferably between about 3.0 g to about 15 g, and mostpreferably between 5 g and 13 g.

The amino acid taurine is important to include in the present invention.The preferred amount of taurine is between about 1.1 g to about 29 g,most preferably between about 2.3 g to about 15 g, and most preferablybetween 3 g and 11 g.

The amino acid lysine is important to include in the present invention.The preferred amount of taurine is between about 0.81 g to about 49 g,most preferably between about 5.3 g to about 35 g, and most preferablybetween 6 g and 18 g.

Another important nutrient is Coenzyme Q-10. The preferred amount ofCoenzyme Q-10 is from about 30 mg to about 1000 mg, most preferably frombetween about 50 mg to 300 mg, and most preferably between about 60 mgto about 180 mg.

The following examples are illustrative only and do not limit theinvention in any fashion.

Example 1

Ingredient Amount Fish Oil 70 mg Selenium (from Selenium yeast) 2500 mcgBeta Carotene 1000 iu Vitamin D3 100 iu Vitamin K 15 mcg Vitamin B6 0.5mg Vitamin B12 1 mcg Folic Acid 250 mcg Zinc 5.0 mg Chromium 25 mcgMolybdenum 15 mcg Glutamine 20 g Arginine 5.1 g Taurine 3.2 g Lysine 7.3g CoQ-10 50 mg Niacin 2.1 mg Riboflavin 600 mcg Thiamin 530 mcg Biotin 2mg Calcium 200 mg Iron 3 mg Phosphorous 213 mg Iodine 35 mg Copper 500mcg Manganese 570 mcg Inositol 1.2 g Sucrose 3.5 g Whey Protein Isolate0.75 g Non-Fat Milk 0.2 g Rice Protein 0.23 g Calcium Caseinate 0.14 gSoy Lecithin 0.1 g

The above ingredients were admixed and shaken until homogeneous blendwas obtained. The blended composition was poured into 250 mL of water,mixed and then consumed via drinking.

Example 2

Ingredient Amount Fish Oil 70 mg Selenium (from Selenium yeast) 2500 mcgBeta Carotene 1000 iu Vitamin D3 100 iu Vitamin K 15 mcg Vitamin B6 0.5mg Vitamin B12 1 mcg Folic Acid 250 mcg Iron 3 mg Phosphorous 213 mgIodine 35 mg Copper 500 mcg Manganese 570 mcg Inositol 1.2 g Sucrose 3.5g Whey Protein Isolate 0.75 g Non-Fat Milk 0.2 g Rice Protein 0.23 gCalcium Caseinate 0.14 g Soy Lecithin 0.1 g

The above ingredients were admixed and shaken until homogeneous blendwas obtained. The blended composition was poured into 250 mL of water,mixed and then consumed via drinking.

Example 3

Ingredient Amount Fish Oil 90 mg Selenium (from Selenium yeast) 2540 mcgBeta Carotene 1300 iu Vitamin D3 80 iu Vitamin K 15 mcg Vitamin B6 0.5mg Vitamin B12 1 mcg Folic Acid 250 mcg Zinc 3.0 mg Chromium 25 mcgMolybdenum 25 mcg Glutamine 29 g Arginine 7.1 g Taurine 3.2 g Lysine 7.6g CoQ-10 100 mg Manganese 570 mcg Inositol 2.7 g Sucrose 3.5 g WheyProtein Isolate 0.75 g Non-Fat Milk 0.2 g Rice Protein 0.23 g CalciumCaseinate 0.14 g Soy Lecithin 0.1 g

The above ingredients were admixed and shaken until homogeneous blendwas obtained. The blended composition was poured into 250 mL of water,mixed and then consumed via drinking.

Example 4

Ingredient Amount Fish Oil 110 mg Selenium (from Selenium yeast) 1500mcg Beta Carotene 200 iu Vitamin D3 100 iu Vitamin K 15 mcg Vitamin B60.5 mg Vitamin B12 1 mcg Folic Acid 250 mcg Zinc 5.0 mg Chromium 25 mcgMolybdenum 15 mcg Glutamine 20 g Arginine 5.1 g Taurine 3.2 g Lysine 7.3g CoQ-10 50 mg Niacin 2.1 mg Riboflavin 600 mcg Thiamin 530 mcg Biotin 2mg Calcium 200 mg Iron 3 mg Phosphorous 213 mg Iodine 35 mg Copper 500mcg Manganese 570 mcg Inositol 1.2 g Sucrose 3.5 g Whey Protein Isolate0.75 g Non-Fat Milk 0.2 g Rice Protein 0.23 g Calcium Caseinate 0.14 gSoy Lecithin 0.1 g

The above ingredients were admixed and shaken until homogeneous blendwas obtained. The blended composition was poured into 250 mL of water,mixed and then consumed via drinking.

Example 5

Ingredient Amount Fish Oil 90 mg Selenium (from Selenium yeast) 1560 mcgBeta Carotene 900 iu Vitamin D3 92 iu Vitamin K 23 mcg Vitamin B6 5.5 mgVitamin B12 3 mcg Folic Acid 250 mcg Zinc 6.0 mg Chromium 25 mcgMolybdenum 15 mcg Glutamine 23 g Arginine 5.1 g Taurine 2.2 g Lysine 7.3g CoQ-10 50 mg Niacin 2.1 mg Riboflavin 600 mcg Thiamin 530 mcg Biotin 2mg Calcium 200 mg Iron 3 mg Phosphorous 213 mg Iodine 35 mg Copper 500mcg Manganese 570 mcg Inositol 1.2 g Sucrose 3.5 g Whey Protein Isolate0.75 g Non-Fat Milk 0.2 g Rice Protein 0.23 g Calcium Caseinate 0.14 gSoy Lecithin 0.1 g

The above ingredients were admixed and shaken until homogeneous blendwas obtained. The blended composition was poured into 250 mL of water,mixed and then consumed via drinking.

Example 6

Ingredient Amount Fish Oil 70 mg Selenium (from Selenium yeast) 2500 mcgBeta Carotene 1000 iu Vitamin D3 100 iu Vitamin K 15 mcg Vitamin B6 0.5mg Vitamin B12 1 mcg Folic Acid 250 mcg Zinc 5.0 mg Chromium 25 mcgMolybdenum 15 mcg Glutamine 20 g Arginine 5.1 g Taurine 3.2 g Lysine 7.3g CoQ-10 50 mg Biotin 2 mg Calcium 200 mg Iron 3 mg Phosphorous 213 mgIodine 35 mg Copper 500 mcg Manganese 570 mcg Inositol 1.2 g Sucrose 3.5g Whey Protein Isolate 0.75 g Rice Protein 0.23 g Calcium Caseinate 0.14g Soy Lecithin 0.1 g

The above ingredients were admixed and shaken until homogeneous blendwas obtained. The blended composition was poured into 250 mL of water,mixed and then consumed via drinking.

What is claimed is:
 1. An orally administrable nutritional compositioneffective for both reducing cachectic symptoms and suppressingneoplastic growth in a cancer patient, comprising: 5 μg to 500 μgselenium yeast; 0.5 mg to 1.5 g fish oil, the fish oil having a combinedEPA/DHA content of between 10% to 90% and an EPA/DHA ratio of between1:5 and 5:1; 500 iu to 10,000 iu beta carotene; 5 g to 13 g arginine; 10g to 50 g glutamine; 6 g to 18 g lysine; milk protein; rice protein; andinositol.
 2. The nutritional composition of claim 1, wherein theselenium yeast is in an amount from 10 μg to 250 μg.
 3. The nutritionalcomposition of claim 1, wherein the selenium yeast is in an amount from25 μg to 150 μg.
 4. The nutritional composition of claim 1, wherein theselenium yeast is one or more of the group consisting of: Saccharomycescerevisiae, Saccharomyces exiguous, Saccharomyces pastorianus,Saccharomyces boulardii, Saccharomyces bayanus, Saccharomyces eubayanus,Saccharomyces florentinus, and Saccharomyces fragilis.
 5. Thenutritional composition of claim 1, wherein the fish oil has an EPA/DHAcontent of between 30% to 70%.
 6. The nutritional composition of claim1, wherein the fish oil has an EPA/DHA content of between 40% to 60%. 7.The nutritional composition of claim 1, wherein the fish oil has anEPA/DHA ratio of about 2:1.
 8. The nutritional composition of claim 1,wherein the fish oil has an EPA/DHA ratio of about 3:2.
 9. Thenutritional composition of claim 1, wherein the beta carotene is in anamount between 1500 iu and 7500 iu.
 10. The nutritional composition ofclaim 1, wherein the beta carotene is in an amount between 1000 iu and3000 iu.
 11. The nutritional composition of claim 1, wherein thenutritional composition additionally comprises 5 mg to 1500 mgresveratrol-containing extract, the resveratrol containing extractcomprising between 50% and 98% resveratrol.
 12. The nutritionalcomposition of claim 1, wherein the nutritional composition additionallycomprises one or more vitamins, the one or more vitamins selected fromthe group of: between 50 iu and 3000 iu vitamin D3, between 2.5 μg to250 μg vitamin K, between 0.1 mg to 100 mg vitamin B6, and between 0.3μg to 900 μg vitamin B12.
 13. The nutritional composition of claim 1,wherein the nutritional composition additionally comprises between 25 μgto 1000 μg folic acid.
 14. The nutritional composition of claim 1,wherein the nutritional composition additionally comprises one or moreminerals, the one or more minerals being selected from the group of:between 0.65 μg to 4000 μg zinc, and between 50 μg to 500 μg chromiumbetween 2.5 μg to 1000 μg molybdenum.
 15. The nutritional composition ofclaim 1, wherein the nutritional composition additionally comprisesbetween 30 mg to 1000 mg coenzyme Q-10.
 16. The nutritional compositionof claim 1, wherein the milk protein is selected from the groupconsisting of whey protein, casein, and non-fat milk.